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Comparison · NCT03389555-5ed8d5db

Vitamin C, Vitamin B1, Corticosteroids vs Placebo: Renal Failure

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Vitamin C, Vitamin B1, Corticosteroids vs Placebo: Renal Failure. Trial comparisons, record NCT03389555-5ed8d5db. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03389555-5ed8d5db

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3170.2340.413wilson
Risk in group 20.2730.1950.368wilson
Risk difference, group 1 minus group 20.0441-0.08180.168newcombe hybrid score
Risk ratio, group 1 over group 21.160.7551.79log
Odds ratio, group 1 over group 21.240.6722.27log
Number needed to treat, for one more participant with the outcome on Vitamin C, Vitamin B1, Corticosteroids than on Placebo22.7from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Vitamin C, Vitamin B1, Corticosteroids
The combination of vitamin C, vitamin B1, hydrocortisone :~* Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days~* Vitamin B1 (thiamine) 100mg every 6 hours x 4-days~* Hydrocortisone 50mg every 6 hours x 4-days~vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.
32101OG000
Group 2PlaceboNormal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components~Normal saline: Normal saline (0.9% NaCl solution) volume to match all components2799OG001

Outcome

Type
SECONDARY
Title
Renal Failure
Description
Development of renal failure as defined by a Kidney Disease Improving Global Outcomes \[KDIGO\] stage 3 or higher. There are 3 stages in the KDIGO scale with stage 3 being the worst (corresponds to renal failure).~Stage 1- serum creatinine 1.5 to 1.9 times baseline OR an increase in serum creatinine ≥ 0.3 mg/dL OR urine output \< 0.5ml/kg/hour for 6-12 hours. Stage 2- serum creatinine 2.0-2.9 times baseline OR urine output \<0.5mg/kg/hour for ≥ 12 hours Stage 3- serum creatinine 3.0 times baseline (or serum creatinine of more than or equal to 4.0 mg/dl with an acute increase of at least 0.5 mg/dl) (OR) Urine output less than 0.3 ml/kg/hour for 24 hours or anuria for 12 hours or new renal replacement therapy
Time frame
Enrollment until 7-days or discharge from the ICU
Population

Source ClinicalTrials.gov

Trial

Title
Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial
NCT number
NCT03389555
Phases
PHASE2, PHASE3
Conditions
Sepsis, Septic Shock, Metabolic Disturbance
Interventions
vitamin C, vitamin B1, hydrocortisone, Normal saline
Lead sponsor
Beth Israel Deaconess Medical Center
Results first posted
2021-01-29

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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